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FDA 510(k) Application Details - K002566
Device Classification Name
Activator, Ultraviolet, For Polymerization
More FDA Info for this Device
510(K) Number
K002566
Device Name
Activator, Ultraviolet, For Polymerization
Applicant
LUMALITE, INC.
2810 VIA ORANGE WAY, STE. B
SPRING VALLEY, CA 91978 US
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Contact
JOSEPH M FOREHAND
Other 510(k) Applications for this Contact
Regulation Number
872.6070
More FDA Info for this Regulation Number
Classification Product Code
EBZ
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More FDA Info for this Product Code
Date Received
08/17/2000
Decision Date
10/19/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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